Associate Regulatory Affairs, Human Health Diagnostics

Job not on LinkedIn

November 14

🚗 Michigan – Remote

Although this job is listed in Michigan, this company may be open to hiring remote in other states.

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

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Eurofins

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Science • Biotechnology • Healthcare Insurance

Eurofins is a global leader in testing and laboratory services. With approximately 62,000 employees and over 900 laboratories across 62 countries, the company provides a wide range of testing services across various industries. Eurofins offers services such as food and feed testing, consumer product testing, genomic services, clinical diagnostics, forensic services, environment testing, and pharmaceutical testing. The company is committed to scientific innovation and sustainability, and it plays a critical role in testing for health, safety, and environmental impacts worldwide.

10,000+ employees

Founded 1987

🔬 Science

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $30M Grant on 2021-10

📋 Description

• Prepare, review and submit regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files) • Ensure compliance with FDA, EU IVDR, and other international regulatory requirements • Utilize checklist, symbol standards, and regulatory guidances to ensure label compliance with FDA and global regulatory expectations • Collaborate with business partners to assure timely review, approval and processing of regulatory documents • Utilize systems for entry and tracking of regulatory activities • Manage and communicate accurate timelines for deliverables • Assess product changes for global regulatory impact

🎯 Requirements

• Minimum of BS/BA in relevant discipline • 3-5 years direct human health IVD experience and/or minimum 8 years of direct non-IVD human health regulatory experience • Direct experience with 510(k)/CLIA waiver application experience • Preferred: knowledge of SAP, Veeva Vault and Trackwise • Strong verbal and written communication and organizational skills • High level of competency using Microsoft Office suite, Microsoft Word and Excel and Adobe Acrobat • Able to effectively communicate in English with colleagues at all in various levels of the organization • Attention to detail to ensure all expectations for labels are met • Flexibility and capacity to handle multiple tasks at once • Demonstration of a highly effective and deeply committed team player • Consistently models behaviors of accountability, approachability, and ownership • Ability to work independently, while fostering good working relationships across physical distance • Capable of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment • Passionate and Enthusiastic • Demonstrates “can do” energy and follow through.

🏖️ Benefits

• Excellent full time benefits including comprehensive medical coverage • Dental and vision options • Life and disability insurance • 401(k) with company match • Paid vacation and holidays • Yearly goal-based bonus & eligibility for merit-based increases